Smith & Nephew recalls certain ENGAGE Cementless Partial Knee Systems due to higher revision rates than similar implants in global registries. Affected units include specific part numbers and sizes.
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Smith & Nephew is recalling specific partial knee implants that may have a higher revision rate than similar implants in global registries. This means the implants could require more replacements than expected, which is a concern for patients who have had the surgery.
The recall is based on data showing that the revision rate for these implants may be higher than similar implants in global joint replacement registries. This suggests the implants might not perform as well as expected over time, potentially requiring more surgeries.
Patients who received the recalled ENGAGE Cementless Partial Knee System implants are likely affected. Those with the specific part numbers and sizes listed in the recall are at risk of needing additional surgeries.
Check if your implant has part numbers REF 1-10003-100 through REF 1-10003-810, with sizes 1 through 8. The recall covers all batches of these specific components.
Review the part numbers and sizes on your implant to see if they match the recalled list (REF 1-10003-100 to REF 1-10003-810).
The recall is based on data showing the revision rate for these implants may be higher than similar implants in global joint replacement registries.
If your implant matches the recalled part numbers and sizes, you should check with your surgeon about potential next steps, as the recall does not require immediate action.
The recall covers all batches of the specified part numbers and sizes, so no specific batch numbers are listed.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1670-2023 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1670-2023 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
